Trial · NCT05262218
Therapeutic Effect of PBF-680 in Patients With COPD
NCT05262218, Phase 2, Completed, Palobiofarma SL
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Effect of PBF-680 in Patients With COPD. Trials, record NCT05262218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05262218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Effect of PBF-680 in Patients With COPD
- NCT number
- NCT05262218
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 174 participants, actual
- Lead sponsor
- Palobiofarma SL
- Conditions
- COPD
- Interventions
- PBF-680 10mg, Placebo
- First posted
- 2022-03-02
- Last updated
- 2024-04-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the blood eosinophil count | 28 days | Absolute and relative change from baseline (pre-dose ) will be computed. Mean difference will be provided. |
| Secondary | Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1) | 28 days | |
| Secondary | Change from baseline in prebronchodilator FEV1 at 3h post administration | 28 days | |
| Secondary | Change from baseline in postbronchodilator FEV1 at 3h post administration | 28 days | |
| Secondary | Change from baseline in the StGeorge's Respiratory Questionnaire (SGRQ-C) | 28 days | St George's Respiratory Questionnaire Questionnaire is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. it is of 50 items questionnaire divided in two parts Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) Scores range from 0 to 100, with higher scores indicating more limitations. |
| Secondary | Change from baseline in the Baseline Dyspnea Index (BDI)/ Transition Dyspnea Index (TDI) (BDI/TDI) | 28 days | The Baseline Dyspnea Index is scored from 0 to 12 and is only assessed at baseline. The lower the score the worse the dyspnea severity. The Transition Dyspnea Index measures the change in dyspnea severity from the baseline as measured by the Baseline Dyspnea Index. It is rated by seven grades ranging from -3 (major deterioration) to +3 (major improvement). |
| Secondary | Change from baseline in the COPD Assessment Test (CAT) | 28 Days | The COPD Assessment Test (CAT) is questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. Number of items: 8 (one question assessing impact on sleep). Scaling of items:1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. No target score represents the best achievable outcome. |
| Secondary | Change from baseline in the Modified Medical Research Council (MRC) breathlessness scales. | 28 days | The Modified Medical Research Council(MRC) uses a simple grading system to assess a patient's level of breathlessness. It is rated by 4 grades ranging from 0 (best condition) to 4 (worse condition) |
| Secondary | Number of subjects with treatment-related adverse events as assessed by CTCAE v4 | 28 days | Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05262218
GET https://conductscience.org/api/trials/v1/NCT05262218/registered